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FDA 510(k) Application Details - K200939
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K200939
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
Yunyang Industrial Park
Danyang 212300 CN
Other 510(k) Applications for this Company
Contact
Rui Li
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/2020
Decision Date
08/20/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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